Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.
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|ClinicalTrials.gov Identifier: NCT02134470|
Recruitment Status : Unknown
Verified April 2015 by Dr. Martin Schoenfelder, Paracelsus Medical University.
Recruitment status was: Active, not recruiting
First Posted : May 9, 2014
Last Update Posted : April 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Circadian Exercise Testosterone||Drug: Testosterone supplementation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Diagnostic Relevance of Salivary Testosterone Concentrations After Exogene Low-dose Hormone Application as a Screening Method for in Doping Control.|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Chemical testing of saliva is an objective method to quantify steroid hormones. Recent studies indicate that salivary testosterone is significantly higher than in other body fluids. Therefore, saliva may serve as pre-screening parameter to select suspicious cases for further target evaluation. The aim of the present project is to detect administered testosterone in saliva and compare these levels to those in blood and urine. Therefore, each participant represents its own control.
Drug: Testosterone supplementation
Low-dose testosterone supplementation will be facilitated by using hormone patches. For pharmacokinetic aspects circadian profiles of saliva/blood/urine will be measured under native conditions and under exogene hormone application. In addition, cross-reactivity of a standardized exercise bout and hormone application will be of further interest.
- Salivary testosterone concentration [ Time Frame: 2 weeks ]Salivary testosterone concentration will be quantified in relation to circadian time, exercise, and external low-dose hormone application.
- Serum testosterone [ Time Frame: 2 weeks ]Serum testosterone concentration (free/bound) will be quantified in relation to circadian time, exercise, and external low-dose hormone application.
- Circulating microRNA in blood plasma [ Time Frame: 2 weeks ]Circulating microRNA in blood plasma will be screened in relation to circadian time, exercise, and external low-dose hormone application.
- Testosterone in hairs [ Time Frame: 4 weeks ]At onset, 2 weeks and 4 weeks after testosterone application steroid hormone concentration will be quantified in scalp hair.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134470
|Technische Universität München|
|Munich, Bavaria, Germany, 80809|
|Principal Investigator:||Martin Schönfelder, Dr.||Paracelsus Medical Private University Salzburg, AUT|
|Principal Investigator:||Hande Hofmann, Dr.||Technische Universität München, GER|
|Principal Investigator:||Detlef Thieme, Dr.||Institute of Doping Analysis und Sports Biochemistry Dresden in Kreischa, GER|